Manufacturing Associate

Planet Pharma; Novato (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

Planet Pharma Group is seeking a qualified candidate for a position in Novato, California. This role requires understanding biopharmaceutical manufacturing processes and compliance with cGMPs. Candidates should have a Bachelor's degree in a science-related field or engineering, and strong communication skills. Responsibilities include supporting process optimization, writing documentation, and collaborating on projects. The position involves alternating shifts including weekends and requires physical mobility. Strong initiative and the ability to work in teams are essential.

Qualifications

• Understanding of biopharmaceutical manufacturing processes including cell culture and protein purification.
• Knowledge of cGMPs and Quality systems related to Commercial Operations.
• Experience with automation systems like LIMS and MES.

Responsibilities

• Support process optimization and troubleshooting efforts.
• Provide feedback on operational procedures and assist in writing documentation.
• Contribute to team projects and support business system learning.

Skills

Strong communication skills

Ability to work in a team environment

Initiative to identify improvements

Education

Bachelor’s degree in science or engineering

Associate’s degree or Biotech certificate with 2+ years experience

Job description

Shift is Sunday – Tuesday 6:00 p.m. – 7:00 a.m., with alternating Saturdays.

Duties

PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).

TECHNICAL DOCUMENTATION

Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.

QUALITY AND COMPLIANCE

Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

BUSINESS

Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.

WORK ENVIRONMENT / PHYSICAL DEMANDS

• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment.
• The use of personal protective equipment will be required.
• Requires various shift based work and off hours.

Skills

• Strong communication skills–verbal and written
• Ability to work in a team environment which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions

Education

• Bachelor’s degree in science related area or engineering
• Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry